Primary Efficacy Evaluation of Traditional Chinese Medicine in Treating Older Infertile Women

A Preliminary Evaluation of the Efficacy of Traditional Chinese Medicine in Treating Elderly Women With Infertility

This study is a preliminary evaluation of the efficacy of traditional Chinese medicine in the treatment of elderly infertile women.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: traditional Chinese medicine: tonifying kidney Wan

Detailed Description

Research design: initial acceptance of 60 people, 30 in the no intervention group and 30 in the experimental group.

The no intervention group no use Traditional Chinese medicine. The experimental group use Traditional Chinese medicine. Affect natural pregnancy and IVF success factors, the quality of ovarian function plays a very important role. Currently used to predict ovarian follicle inventory indicators, including: age, the total number of small sized ovarian follicles, the first three days of menstrual follicle-stimulating hormone, Anti-Mullerian hormone, inhibin-B.

Research Analysis Chang Gung Memorial Hospital infertility patients using traditional Chinese medicine, more than 40-year-old infertility patients, the most commonly used compound is Zuo Gui Wan. Chinese medicine believes that elderly women with infertility ovulation poor, the main pathogenesis of kidney deficiency. The proportion of domestic infertility patients has increased year by year. Traditional Chinese medicine had become popular and acceptable, but the substantial evidence and treatment consensus of infertility are scanty.

Due to the outbreak of the new crown pneumonia epidemic, which made it difficult to accept the case. Only 17 subjects in the experimental group completed the test. The average age of the subjects was 40.11 ±3.09 years old, and 9 of them were over 40 years old. The AMH before the test was all below 1.2. After three months of treatment with traditional Chinese medicine, 16 subjects had an increase in the number of small sized ovarian follicles. The average total number of small ovarian follicles before the test was 3.06±0.90, and the average increased to 4.53±1.46 after treatment. (P<0.05), which was statistically significant. Eleven subjects showed a decrease in follicle-stimulating hormone on the third day of menstruation after treatment, 9 subjects showed an increase in anti-Mullerian hormone (AMH) value after treatment, and 3 subjects had anti-Mullerian hormone (AMH) values higher than 1.2 after treatment, but they did not reach statistical significance.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33302
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• A. Women aged 35-45, married, without contraception, after 12 months of normal sexual life, did not take any contraceptive measures, and did not successfully conceive women.

B. Blood tests for serum anti-Mullerian hormone ( AMH) less than 1.2, female hormones FSH, LH, E2 blood test is normal.

C. Women who are not planning for IUI or IVF in the next three months. D. Menstrual cycle rules 21-35 days. E. Willing to sign a written consent form.

Exclusion Criteria:

A. Women with contraceptive. B. Vegetarians or have been taking Traditional Chinese medicine allergies. C. The following diseases have occurred in the past six months: cancer, high blood pressure, diabetes, heart disease, stroke, myocardial infarction, hyperthyroidism or hypothyroidism, chronic hepatitis, gastric ulcer, stomach bleeding, chronic constipation or diarrhea, major trauma and surgery, severe uterine and pelvic infections.

D. Because of the need for disease, it is currently necessary to take western medicine for more than three months.

E. Women with abnormal liver function (GOT, GPT greater than 2 times the upper limit of normal).

F. Women with abnormal renal function (serum creatinine > 1.5 mg/dl). G. Poor compliance with medication. H. In the past month, take a Traditional Chinese medicine to treat infertility. I. Take DHEA for the past month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: traditional Chinese medicine; The experimental group use traditional Chinese medicine	Drug: traditional Chinese medicine: tonifying kidney Wan; traditional Chinese medicine : tonifying kidney Wan; Other Names: tonifying kidney Wan I: Zuo Gui Wan; tonifying kidney Wan II :Guilu Erxian
NO_INTERVENTION: non- traditional Chinese medicine; The no intervention group no use traditional Chinese medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum anti-Mullerian hormone (AMH) index	The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by examining serum anti-Mullerian hormone (AMH) index	three months
total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 days).	The efficacy of traditional Chinese medicine in the treatment of infertile women was evaluated by the total number of small ovarian follicles by the ultrasound examination (menstrual cramps 3-5 days).	three months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Tsang-Tang Hsieh, MD, Chang Gung MH IRB

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2019
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: June 2, 2019
• First Submitted That Met QC Criteria: June 2, 2019
• First Posted (ACTUAL): June 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Infertility; Traditional Chinese Medicine(TCM); anti-Mullerian hormone (AMH)
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: IRB201702097A3; Chang Gung MH (CMRPG3H1931)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No